MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-V

Device Problems Break (1069); Inaccurate Flow Rate (1249); Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Headache (1880); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Nausea (1970); Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Please note that this age is the average age of the patients reported in the article.This event was identified during review of scientific literature.The article contained only limited and non-specific device information.The event reported in the source literature could not be matched to information previously reported to medtronic neurosurgery.If information is provided in the future, a supplemental report will be issued.

Event Description

Eric a.Sribnick, frederick h.Sklar, david m.Wrubel.A novel technique for distal shunt revision: retrospective analysis of guidewire-assisted distal catheter replacement.Operative neurosurgery 11 (2015).Doi: 10.1227/neu.0000000000000793 background: ventriculoperitoneal shunt (vps) revision is a common procedure.Disconnection and fracture of the distal catheter remain a common cause of ventriculoperitoneal shunt malfunction.Objective: to describe a novel procedure for peritoneal replacement of the distal catheter by using a guidewire and a modified seldinger technique (guidewire-assisted distal catheter replacement) and retrospectively evaluate the results of the surgical procedure.Methods: between september 2005 and december 2013, 68 patients were treated by a single surgeon (dmw) with distal catheter replacement using our technique.In brief, the previously placed distal catheter was exposed at its entry site into the abdomen.A soft guidewire with hydrophilic coating was inserted down the distal catheter into the peritoneum.The distal catheter was then removed over the guidewire, leaving the guidewire in place.A peel-away sheath and dilator were then inserted over the guidewire, and the dilator and guidewire were removed.The new distal catheter was then passed from the valve to the abdomen and was then fed through the peel-away sheath into the peritoneum.Charts were retrospectively reviewed for preoperative presentation, operative technique, and postoperative outcome.Records were specifically examined for any early or late complications.Results: the mean patient age at surgery was 13 years.No immediate acute complications were noted.Of the 68 total patients, 45 patients had more than 6 months of follow-up.Of the 68 patients, 7 patients required another distal revision after guidewire assisted distal catheter replace ment.Conclusion: distal shunt malfunction due to a mechanical failure is a common reason for shunt revision.We describe a technique for guidewire-assisted distal catheter replacement.Reported events: 68 patients underwent a guidewire-assisted distal revision.15 patients also required a proximal vps revision.Preoperative evaluation of these patients revealed the following symptoms: 37 patients were noted to have headache, 21 were asymptomatic, and 17 had nausea or emesis.Of the 68 total patients, 63 underwent head computed tomography, which showed evidence of ventricular enlargement in 40 patients.A total of 62 patients received a radiographic shunt series, and a fracture of the catheter was seen in 50 patients.In 1 patient, the radiographic shunt series revealed a shortened distal catheter.Shunt valve aspiration (shunt tap) was performed in 10 patients, showing poor proximal flow in 4 patients and poor distal flow in 8 patients.1 patient with guidewire-assisted distal revision needed a further vps revision within 1 month of the original surgery due to blood in the proximal catheter and valve, and the abdominal portion of the vps was exposed but was reimplanted after exploration.1 patient with guidewire-assisted distal revision needed a further vps revision within 1 month of the original surgery where the entire vps was revised due to several blockages noted at exploration.1 patient with guidewire-assisted distal revision needed a further vps revision within 1 month of the original surgery due to cranial wound dehiscence.This patient was the only patient to have a wound infection following revision.2 patients with guidewire-assisted distal revision needed a further distal vps revision within 2 years of the original surgery.1 patient with guidewire-assisted distal revision needed a further distal vps revision approximately 4 years of the original surgery.

• Brand Name: UNKNOWN VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 6982664
• MDR Text Key: 90395551
• Report Number: 2021898-2017-00547
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-V
• Device Catalogue Number: UNKNOWN-V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2017
• Initial Date FDA Received: 10/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13 YR